Analysis of Self-Administered Aspirin Post-Chest Pain to Prevent Cardiovascular Mortality
According to the American Heart Association, someone experiences an acute myocardial infarction (AMI) in the United States every 40 seconds, making it a leading cause of mortality. However, a significant number of AMI deaths occur outside the hospital, with delayed access to medical care being a contributing factor. The International Study of Infarct Survival sought to analyze the potential benefits and risks of self-administering aspirin within 4 hours of experiencing severe chest pain to reduce mortality post-AMI.
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The analysis used a population simulation model with data pooled from the 2019 U.S. Census. It included adults age 40 and older who self-administered 325 mg of aspirin within 4 hours after chest-pain onset (with or without AMI) and continued aspirin treatment for 28 days after AMI diagnosis (standard care). This data was compared to the results of patients who received aspirin therapy more than 4 hours after symptoms began. The primary outcome was estimating the potential number of deaths delayed post-AMI and the increased risk of bleeding associated with aspirin use.
The study found that self-administration of aspirin within 4 hours of chest pain onset resulted in 13,016 deaths delayed in the United States in 2019 among adults age 40 and older. The bleeding deaths due to aspirin use in the same population was 963. Despite the bleeding risk, the researchers suggest that the benefits of aspirin self-administration should be promoted as a simple and cost-effective intervention for reducing AMI mortality.
The findings highlight the need for further research and efforts to scale up aspirin self-administration initiatives to reach more individuals at risk for AMI. (Russo, R. G., et al. (2024). Self‐administration of aspirin after chest pain for the prevention of premature cardiovascular mortality in the United States: A population‐based analysis. Journal of the American Heart Association. Advance online publication. Retrieved May 2024 from https://www.ahajournals.org/doi/10.1161/JAHA.123.032778)
Released: June 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Dequalinium as Potential Treatment for Bacterial Vaginosis
Bacterial vaginosis (BV), a common and recurrent vaginal infection in females of reproductive age, is typically treated with antibiotics, like metronidazole and clindamycin. However, their adverse effects and risk of antibiotic resistance necessitate alternative treatments. A recent study evaluated the efficacy of dequalinium chloride, an antiseptic with broad-spectrum activity against various microorganisms, as a potential nonantibiotic treatment for BV.
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The phase 4, multicenter, triple-blind, parallel clinical trial aimed to compare the safety and efficacy of dequalinium to oral metronidazole, as first-line treatment for BV. The study, which ran from July 2021 to August 2022, recruited 151 premenopausal females (age 18 and older) with BV from Poland, the Czech Republic, and Slovakia. The participants were randomized into two groups receiving either dequalinium or placebo (10-mg intravaginal tablets used once a day for 6 days), or metronidazole or placebo (500-mg oral tablets taken twice a day for 7 days). Patients were asked to keep track of symptoms, tolerability, efficacy, and adverse events in an electronic diary. Two follow-up visits occurred after the start of treatment (on days 7 to 11 and days 20 to 40) for clinical evaluation.
Various measures, including clinical and bacteriologic cure rates, safety profiles, and rate of recurrence, were evaluated over the course of the study. Results showed that dequalinium had similar results to metronidazole in terms of clinical cure rates, with over 90% of patients in both groups showing resolution of symptoms at the first visit (93.1% dequalinium versus 90.6% metronidazole). Furthermore, dequalinium demonstrated better tolerability (60.0% rated dequalinium "very good" versus 38.9% for metronidazole) and fewer adverse events compared to metronidazole (7 versus 11). The rate of BV recurrence, which tends to be high (30% to 70% within 6 months), was the same between the groups.
The study's findings suggest that dequalinium chloride could be considered as first-line treatment for BV due to its comparable efficacy to antibiotics, broader spectrum of activity, better tolerability, and lower likelihood of resistance development. However, the high BV recurrence rate was similar to antibiotics, indicating the need for further research into strategies to prevent recurrence, such as probiotic use. (Raba, G., et al. (2024). Efficacy of dequalinium chloride vs metronidazole for the treatment of bacterial vaginosis: A randomized clinical trial. JAMA Network Open, 7(5), Article e248661. Retrieved May 2024 from https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2818221)
Released: June 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Progestogen Versus Combined Oral Contraceptive for Endometriosis Pain
Endometriosis, affecting up to 1-in-10 women of reproductive age, involves the growth of endometrial-like tissue outside the uterus, leading to severe pelvic pain and infertility. Surgical treatment is common, but recurrence rates are high, with many women undergoing multiple operations. Hormonal treatments, like the combined oral contraceptive pill (COCP) and progestogens, are recommended postsurgery, but it's uncertain which is more effective in preventing pain recurrence.
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PRE-EMPT (Preventing Recurrence of Endometriosis), a multicenter, parallel group, randomized controlled trial, aimed to compare long-acting progestogens (LAPs) with COCP in preventing pain recurrence postsurgery for endometriosis. The study spanned from November 2015 to March 2019 and recruited 405 women ages 16 to 45. Participants underwent laparoscopy for endometriosis, and then were randomized to receive LAP (depot medroxyprogesterone acetate 150 mg IM every 3 months or levonorgestrel-releasing intrauterine system delivering 20 mcg daily for 5 years) or COCP (30-mcg ethinylestradiol and 150-mcg levonorgestrel taken continuously or cyclically each month). The primary outcome was pain recurrence measured via the Endometriosis Health Profile-30 pain domain after 3 years postrandomization.
After 3 years, both LAP and COCP groups showed around a 40% reduction in pain scores from preoperative levels. Both treatments also demonstrated improvements in other quality of life measures, and adverse events were similar between groups and not directly related to trial treatments. However, the study showed that LAPs had an 11% lower rate of treatment failure, and fewer women required further interventions with LAPs compared to COCP (73 versus 97).
Based on these results, providers can assure patients that either class of hormonal drug can help with pain reduction over the next 3 years after endometriosis surgery, but LAPs may reduce the risk of needing additional treatments and surgeries. Future research should explore newer hormonal treatments and focus on early, noninvasive diagnosis to improve long-term pain management and quality of life for endometriosis patients. (Cooper, K. G., et al. (2024). Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: The PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial. BMJ, 385, Article e079006. Retrieved May 2024 from https://www.bmj.com/content/385/bmj-2023-079006)
Released: June 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Perioperative Nivolumab for Non-Small-Cell Lung Cancer
Nivolumab, an antibody targeting programmed death-1, in combination with chemotherapy is standard neoadjuvant treatment for patients with resectable non-small-cell lung cancer (NSCLC). Studies, including the landmark CheckMate 816 trial, showed significant improvements in event-free survival and pathologic complete response with this combination compared to chemotherapy alone. Based on these results, researchers questioned whether a perioperative approach, combining neoadjuvant therapy with nivolumab, followed by surgery and adjuvant therapy, could reduce disease relapse rates, and enhance clinical outcomes by bolstering antitumor immunity.
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The CheckMate 77T trial, a phase 3, randomized, double-blind study, compared perioperative nivolumab to chemotherapy alone in resectable NSCLC patients. The trial, between November 2019 and April 2022, randomized 461 patients to nivolumab or chemotherapy. The first group received four cycles of neoadjuvant nivolumab and chemotherapy, followed by definitive surgery, and then 1 year of adjuvant treatment with nivolumab. The second group had four cycles of a placebo and chemotherapy, plus definitive surgery, and adjuvant treatment with a placebo for 1 year.
Results showed significantly longer event-free survival at 18 months with perioperative nivolumab (70.2%) compared to chemotherapy alone (50.0%), alongside higher rates of pathologic complete response (25.3% nivolumab versus 4.7% chemotherapy) and major pathologic response (35.4% nivolumab versus 12.1% chemotherapy). Safety profiles were comparable between groups, with no new safety signals observed with perioperative nivolumab. Adverse events, including immune-related ones, were manageable, and surgical outcomes were similar between treatment arms.
This trial points to the efficacy of perioperative nivolumab in improving event-free survival, pathologic response, and disease-related symptoms compared to chemotherapy alone in resectable NSCLC patients. These findings support the role of immunotherapy in perioperative treatment strategies for NSCLC, potentially offering long-term clinical benefits as data continue to mature. (Cascone, T., et al. (2024). Perioperative nivolumab in resectable lung cancer. NEJM, 390(19), 1756–769. Retrieved May 2024 from https://www.nejm.org/doi/full/10.1056/NEJMoa2311926)
Released: June 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer